HAN-I-FOAM  - alcohol liquid 
Momar Incorporated

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Han-I-Foam 6585 Drug Facts and Label

Drug Facts Box OTC-Active Ingredient Section

Ethyl Alcohol 62% v/v

Drug Facts Box OTC-Purpose Section

Antiseptic

Drug Facts Box OTC-Indications & Usage Section

for hand-washing to decrease bacteria on the skin, only when water is not available

Drug Facts Box OTC-Warnings Section

FLAMMABLE, keep away from fire and flames

For external use only

Drug Facts Box OTC-When Using Section

do not get into eyes

if contact occurs, rinse eyes thoroughly with water

Drug Facts Box OTC-Stop Use Section

irritation and redness develop

Drug Facts Box OTC-Keep Out of Reach of Children Section

if swallowed, get medical help or contact a Poison Control Center right away

Drug Facts Box OTC-Dosage & Administration Section

press pump twice to deliver two squirts (about a quarter size) of foaming product onto the palm of your hand

rub hands together and allow to dry without wiping

Drug Facts Box OTC-Inactive Ingredient Section

water, DEA-C8-18 perfluoroalkylethyl phosphate, propylene glycol, fragrance

Han-I-Foam 6585 50 ml

6585Z1Q610.jpg Han-I-Foam 50ml  image of bottle label

HAN-I-FOAM  
alcohol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63533-855
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.62 mL  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DIETHANOLAMINE BIS(C8-C18 PERFLUOROALKYLETHYL)PHOSPHATE (UNII: 4J55VM509S)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63533-855-06 1 in 1 BOX
1 800 mL in 1 BAG
2 NDC:63533-855-17 532 mL in 1 BOTTLE, PLASTIC
3 NDC:63533-855-24 118 mL in 1 BOTTLE, PLASTIC
4 NDC:63533-855-01 1200 mL in 1 CARTRIDGE
5 NDC:63533-855-03 350 mL in 1 CARTRIDGE
6 NDC:63533-855-05 540 mL in 1 BOTTLE, PLASTIC
7 NDC:63533-855-07 700 mL in 1 BAG
8 NDC:63533-855-09 2000 mL in 1 CARTRIDGE
9 NDC:63533-855-10 1000 mL in 1 CARTRIDGE
10 NDC:63533-855-11 1000 mL in 1 BOTTLE, PLASTIC
11 NDC:63533-855-12 1000 mL in 1 BAG
12 NDC:63533-855-13 800 mL in 1 BAG
13 NDC:63533-855-14 3785 mL in 1 BOTTLE, PLASTIC
14 NDC:63533-855-15 946 mL in 1 BOTTLE, PLASTIC
15 NDC:63533-855-28 149 mL in 1 BOTTLE, PLASTIC
16 NDC:63533-855-27 800 mL in 1 CARTRIDGE
17 NDC:63533-855-55 208200 mL in 1 DRUM
18 NDC:63533-855-08 1 in 1 BOX
18 1000 mL in 1 BAG
19 NDC:63533-855-16 236 mL in 1 BOTTLE, PLASTIC
20 NDC:63533-855-18 50 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 09/01/2009
Labeler - Momar Incorporated (003266616)
Registrant - ABC Compounding Co., Inc. (003284353)
Establishment
Name Address ID/FEI Business Operations
ABC Compounding Co., Inc. 003284353 manufacture(63533-855)

Revised: 11/2012
Document Id: 6b6a6943-c0fe-4ead-9200-7d320ef3e86d
Set id: 5045c8ff-7591-47b0-b219-aba27a6fe039
Version: 1
Effective Time: 20121101
 
Momar Incorporated